Guidelines, Codes, and Regulations

2021 ◽  
Author(s):  
Daniel K. Nelson ◽  
David Forster
Keyword(s):  
United States ◽  
Biomedical Research ◽  
Human Subjects ◽  
Codes Of Conduct ◽  
The United States ◽  
Historical Evolution ◽  
Human Subjects Research ◽  
Regulatory Bodies ◽  
Universal Codes ◽  
Patchwork Quilt

Research involving human subjects is increasingly global in scope. This research is governed by over 1,000 guidelines, codes, and regulations spanning 130 countries. While there have been some attempts to construct international codes of conduct, particularly in the area of biomedical research, the reality is that these universal codes are superimposed over national and institutional norms, resulting in idiosyncrasies and discrepancies. Even within the United States as a single example, human subjects research is subject to a “patchwork quilt” of regulation, depending on the nature of the research and the source of funding. This chapter will provide an overview of these governing standards, recounting their historical evolution, discussing their key elements, and describing the challenges faced by researchers, sponsors, and regulatory bodies who must navigate this landscape.

scholarly journals The Suitability of IRB Liability

2005 ◽  
Vol 67 (2) ◽  
Author(s):  
Sharona Hoffman ◽  
Jessica Wilen Berg
Keyword(s):  
United States ◽  
Biomedical Research ◽  
Clinical Studies ◽  
Human Subjects ◽  
The United States ◽  
Institutional Review Boards ◽  
Federal Regulations ◽  
Institutional Review ◽  
Research Oversight ◽  
Oversight System

The biomedical research oversight system in the United States delegates most responsibilities to local review entities known as institutional review boards (IRBs). The IRBs are charged with responsibility for safeguarding the welfare of research participants and ensuring that clinical studies involving human subjects comply with federal regulations.

Science, Politics, and the Pandemic

2020 ◽  
Vol 119 (820) ◽  
pp. 303-309
Author(s):  
J. Nicholas Ziegler
Keyword(s):  
United States ◽  
Biomedical Research ◽  
Scale Up ◽  
Political Leadership ◽  
The United States ◽  
Scientific Advice ◽  
The United Kingdom ◽  
Effective Policy ◽  
Scientific Expertise ◽  
The Uk

Comparing the virus responses in Germany, the United Kingdom, and the United States shows that in order for scientific expertise to result in effective policy, rational political leadership is required. Each of these three countries is known for advanced biomedical research, yet their experiences in the COVID-19 pandemic diverged widely. Germany’s political leadership carefully followed scientific advice and organized public–private partnerships to scale up testing, resulting in relatively low infection levels. The UK and US political responses were far more erratic and less informed by scientific advice—and proved much less effective.

scholarly journals Culturally Relevant Human Subjects Protection Training: A Case Study in Community-Engaged Research in the United States

2017 ◽  
Vol 20 (1) ◽  
pp. 107-114 ◽  
Author(s):  
Jennifer Kue ◽  
Laura A. Szalacha ◽  
Mary Beth Happ ◽  
Abigail L. Crisp ◽  
Usha Menon
Keyword(s):  
United States ◽  
Culturally Relevant ◽  
Human Subjects ◽  
The United States ◽  
Community Engaged Research

Research Ethics as Social Policy. Some Lessons from Experiences in Canada and in the United States

2003 ◽  
Vol 24 (2) ◽  
pp. 61-85
Author(s):  
Michael McDonald ◽  
Eric Meslin
Keyword(s):  
United States ◽  
Human Subjects ◽  
Ethics Committees ◽  
The United States ◽  
Prior Review ◽  
Emerging Trends ◽  
Policies And Procedures ◽  
Behavioural Research ◽  
Individual Informed Consent ◽  
Protection Of Human Subjects

For more than tlrree decades, Canada and the United States have used similar mechanisms for ensuring the protection of human subjects involved in biomedical and behavioural research: written guidelines that specify the substantive and procedural requirements of investigators and institutions; individual informed consent, and prior review and approval by interdisciplinary committees. Given the proximity of the countries to one another and the massive amount of trade and commerce that transpires between them, it is not surprising that these countries share a number of values in research. During the past fifteen years, however, both countries have experienced new challenges to their systems. Sorne of the challenges relate to new trends in research, such as genetics studies and massively increased private sector funding for pharmacological research. Other challenges relate to emerging trends in oversight policies and procedures, such as accreditation of ethics committees. Research reflects a country's particular social policies. The responses to emerging trends illustrate how such policies are evolving in sometimes quite different ways in both countries. This reflects the related but distinct political cultures and structures in the two countries. This paper will explore these trends and emerging responses, drawing lessons from each.

The American Jewish Intelligentsia, the Claims of Humor—and the Case of Lenny Bruce

2021 ◽  
pp. 232-250
Author(s):  
Stephen J. Whitfield
Keyword(s):  
United States ◽  
Subject Matter ◽  
Codes Of Conduct ◽  
The United States ◽  
Communal Life ◽  
Stand Up Comedy ◽  
Key Characteristics ◽  
The Social ◽  
Jewish Humor ◽  
American Jewish

Several major American Jewish scholars and intellectuals have addressed the vitality and the pertinence of Jewish humor, seeing in it an entrée not only into key characteristics of communal life but also into the texture of reality itself. These academicians and critics have exposed the encounter between stand-up comedy and the social and political peculiarities of Jewish life in the United States. No comedian attracted more sustained attention than Lenny Bruce, whose career enlarged the contours of what could explored in night clubs and on long-playing records. Perhaps no satirist took greater risks, or exposed himself to greater legal danger, in both subject matter and in language. No predecessor was more willing to flaunt his own Jewish sensibility, or to present with such cynicism the hypocrisies inherent in the codes of conduct by which respectable America professed to live—which is what made Bruce the object of serious interest.

scholarly journals Evaluating the prevalence and quality of conference codes of conduct

2019 ◽  
Vol 116 (30) ◽  
pp. 14931-14936 ◽  
Author(s):  
Alicia J. Foxx ◽  
Rebecca S. Barak ◽  
Taran M. Lichtenberger ◽  
Lea K. Richardson ◽  
Aireale J. Rodgers ◽  
...  
Keyword(s):  
United States ◽  
Codes Of Conduct ◽  
Sexual Misconduct ◽  
Social Behaviors ◽  
The United States ◽  
Underrepresented Groups ◽  
Power Differentials ◽  
Identity Based ◽  
Academic Conferences

Efforts to increase inclusion in science face multiple barriers, including cultural and social behaviors in settings such as academic conferences. Conferences are beneficial, but the culture can promote inequities and power differentials that harm historically underrepresented groups. Science suffers when conference culture propagates exclusion and discrimination that leads to attrition of scientists. Codes of conduct represent a tool to shift conference culture to better support diverse scientists and clearly detail unacceptable behaviors. We examined the prevalence and content of codes of conduct at biology conferences in the United States and Canada. We highlight how codes of conduct address issues of sexual misconduct and identity-based discrimination. Surprisingly, only 24% of the 195 surveyed conferences had codes. Of the conferences with codes, 43% did not mention sexual misconduct and 17% did not mention identity-based discrimination. Further, 26% of these conferences failed to include a way to report violations of the code and 35% lacked consequences for misconduct. We found that larger and national conferences are more likely to have codes than smaller (P = 0.04) and international or regional (P = 0.03) conferences. Conferences that lack codes risk creating and perpetuating negative environments that make underrepresented groups feel unwelcome, or worse, actively cause harm. We recommend that conferences have codes that are easily accessible, explicitly address identity-based discrimination and sexual misconduct, provide channels for anonymous impartial reporting, and contain clear consequences. These efforts will improve inclusivity and reduce the loss of scientists who have been historically marginalized.

scholarly journals 2018: A watershed year for psychedelic science

2019 ◽  
Vol 5 ◽  
pp. 205032451987228 ◽  
Author(s):  
Jacob S Aday ◽  
Christopher C Davoli ◽  
Emily K Bloesch
Keyword(s):  
United States ◽  
Media Coverage ◽  
The United States ◽  
Ballot Initiatives ◽  
The Public ◽  
Psychedelic Drugs ◽  
The Status ◽  
Regulatory Bodies ◽  
The Public Sphere

While interest in the study of psychedelic drugs has increased over much of the last decade, in this article, we argue that 2018 marked the true turning point for the field. Substantive advances in the scientific, public, and regulatory communities in 2018 significantly elevated the status and long-term outlook of psychedelic science, particularly in the United States. Advances in the scientific community can be attributed to impactful research applications of psychedelics as well as acknowledgement in preeminent journals. In the public sphere, Michael Pollan’s book How to Change Your Mind was a commercial hit and spurred thought-provoking, positive media coverage on psychedelics. Unprecedented psychedelic ballot initiatives in the United States were representative of changes in public interest. Finally, regulatory bodies began to acknowledge psychedelic science in earnest in 2018, as evidenced by the designation of psilocybin-assisted psychotherapy to “breakthrough therapy” status for treatment-resistant depression by the U.S. Food and Drug Administration (FDA). In short, 2018 was a seminal year for psychedelic science.

Current Developments in Autonomous Vehicle Policy in the United States: Federalism’s Influence in State and National Regulatory Law and Policy

Global Jurist ◽  
2017 ◽  
Vol 18 (1) ◽  
Author(s):  
Christopher Salatiello ◽  
Troy B. Felver
Keyword(s):  
United States ◽  
Autonomous Vehicles ◽  
New Technologies ◽  
Autonomous Vehicle ◽  
The United States ◽  
Great Promise ◽  
Maximum Benefit ◽  
Regulatory Law ◽  
Regulatory Bodies ◽  
Self Driving Cars

Abstract With the advent of autonomous vehicles, especially self-driving cars, there is great promise for society. However, cars are not islands; they operate in a community of vehicles. Laws and regulations are crafted to allow the maximum benefit for the community while imposing the fewest costs. Unfortunately, a full accounting of these benefits and costs is not entirely clear at promulgation. Because the technologies and how they will be used are so uncertain, regulatory bodies have to try to build on what they have done in the past, sometimes successfully and sometimes unevenly. This paper will examine several regulatory attempts involving these new technologies in the United States, both on the federal and state levels. Also considered will be the interaction of these regulations under a federal system with defined and specific responsibilities for both sovereigns. A view on future developments is provided to gauge the directions additional regulation could take. Finally, generalizable lessons from this approached will be summarized.

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